Reliability Engineer

About the position

The Reliability Engineer will help foster a Reliability Culture by establishing Reliability Centered Maintenance (RCM) procedures and initiatives for the Summit, NJ Manufacturing site. The Reliability Engineer will help systematically achieve adequate maintenance practices and asset lifecycle measures to help meet Engineering & Production Technical Services' priorities, as well as comply with Global policies and goals. The Reliability Engineer will contribute to the growth and success of the Reliability Excellence program at the Summit site. The primary objective of the Reliability Engineer will be to ensure the reliability and efficiency of our manufacturing, laboratory, and facility equipment that supports the critical mission of delivering life-saving cell therapies to patients in need. This position reports to the Senior Manager, Reliability Engineering.

Responsibilities

• Knowledge of Reliability Centered Maintenance (RCM), Computerized Maintenance Management System (CMMS), and Predictive Maintenance (PdM) technology software.
• Ability to prepare and present comprehensive reports with recommendations or needed changes.
• Ability to be effective in both a team environment and an individual contributor role.
• Knowledgeable in engineering principles related to instrumentation in a biopharmaceutical process.
• Knowledge of regulatory, environmental, and cGMP requirements along with knowledge of manufacturing facilities, utility operations, and building maintenance operations.
• Intermediate knowledge of electrical, mechanical, critical utilities such as compressed gas, HVAC systems, equipment functions, and maintenance practices.
• Knowledge of typical CAR-T Cell Therapy upstream and downstream processing and support equipment.
• Improves reliability of the systems, equipment, and operations by utilizing analytical, statistical tools and instrumentation.
• Conducts and/or reviews failure modes and effects analysis (FMEA) to ensure proper maintenance tasks and intervals are established for all equipment in the RCM program to achieve the desired reliability.
• Communicates with other departments (Manufacturing, QC, and Warehouse) to develop and meet reliability requirements to ensure strategic manufacturing goals are being met.
• Prepares presentation slides to describe the status, benefits, and opportunities within RCM based recommendations and/or solutions.
• Performs root cause failure analysis (RCFA) for chronic or critical equipment failures and identifies corrective actions necessary to increase future reliability.
• Reviews maintenance equipment history to provide proactive solutions to potential problems affecting reliability and/or cost.
• Ensures all new equipment meets or exceeds standards for reliability.
• Works directly with the Maintenance group to provide guidance and decision making regarding the maintenance procedures and process to ensure the reliability goals for the plant are met.
• Supports the execution of capital projects, when required. Ensures EHS and cGMP practices and regulations are considered in all activities related to the owned system, projects, maintenance, etc.
• Supports predictive maintenance initiatives.
• Provides support to other Engineering and Maintenance Department functions as required by plant needs and unplanned events.
• Develops and follows strict Standard Operating Procedures (SOP's) to ensure quality, and that compliant maintenance activities are completed in a timely manner.
• Collaborating with cross-functional teams, assist in collecting and analyzing reliability data, equipment performance metrics, and maintenance records.
• Maintains a high level of multi-tasking ability in conjunction with proven organizational skills.

Requirements

• Bachelor's degree required in Engineering field or Life Sciences.
• 7 years of GMP experience working within the pharmaceutical industry or other regulated industry.
• Minimum of 2 years direct Engineering experience.

Nice-to-haves

• 1-2 years of experience with cell and gene therapy.
• Operational Excellence.
• Reliability Engineering experience.

Benefits

• Competitive benefits, services and programs that provide resources to pursue goals at work and in personal lives.